Brief Summary

The goal of this study is to evaluate the efficacy of using the Vivaer low-temperature radio-frequency (LTRF) device to reshape ex-vivo human nasal or auricular cartilage for use in cosmetic and functional septorhinoplasty. The investigators hope to answer the following questions:

1.How many LTRF treatments are needed to achieve the desired shape in a given cartilage specimen
2.How does an LTRF treatment quantitatively affect both length and angulation of a cartilage specimen
3.How does physician satisfaction with cosmetic outcome compare to cases treated with existing septorhinoplasty techniques
4.How do changes in patient reported measures of nasal obstruction (NOSE score) pre- and post-surgery compare to cases treated with existing septorhinoplasty techniques
5.Does using LTRF during septorhinoplasty significantly increase total operative time
6.Are rates of adverse events when using LTRF different from cases treated with existing septorhinoplasty techniques

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

13mo left

Started Oct 2025

Geographic Reach

1 country

6 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.6 years study duration

Study Progress35%

Oct 2025Jun 2027

First Submitted

Initial submission to the registry

June 16, 2025

Completed

8 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed

4 months until next milestone

Study Start

First participant enrolled

October 14, 2025

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

1.6 years

First QC Date

June 16, 2025

Last Update Submit

November 24, 2025

Conditions

Nasal Valve Collapse Nose Enhancement

Keywords

low-temperature radio-frequencynasal valve collapseseptorhinoplastyseptoplastyrhinoplastycartilage reshaping

Outcome Measures

Primary Outcomes (1)

Number of treatments needed to reach desired shape
The primary outcome measure will be the efficacy of reshaping cartilage from straight to curved and from curved to straight for use in septorhinoplasty. The number of treatments needed to create the desired shapes and curvatures will be measured for each cartilage specimen.
Immediately pre and post intervention (intraoperative)

Secondary Outcomes (4)

Change in specimen curvature
Immediately pre and post intervention (intraoperative)
Change in specimen length
Immediately pre and post intervention (intraoperative)
Nasal Obstruction Symptom Evaluation (NOSE) score
Baseline and one month
Physician satisfaction with cosmetic outcome
Baseline and one month

Other Outcomes (2)

Reimplantation of LTRF-shaped specimens
Immediately pre and post intervention (intraoperative)
Time spent using low-temperature radiofrequency device
Immediately pre and post intervention (intraoperative)

Study Arms (1)

Low-temperature radio-frequency reshaping intervention

EXPERIMENTAL

All enrolled subjects will receive the intervention outlined in the section titled "Study Design".

Device: Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilage

Interventions

Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilageDEVICE

The device settings will be set per the manufacturer's instructions: temperature = 60° C, power = 4 W, treatment time = 18 seconds, and cooldown = 12 seconds. For curved-to-straight (CTS) samples (natively curved cartilage to be remolded to be flat), the cartilage specimens will be placed on a blue towel on a flat surface with the transmission medium over top and treated. For straight-to-curved (STC) samples (natively flat cartilage to be remolded to be curved), cartilage specimens will be placed along the inner surface of various shallow, plastic, cylindrical objects with the transmission medium over top and treated. Various device settings may be tested for reshaping efficacy.

Low-temperature radio-frequency reshaping intervention

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients 18 years and older undergoing functional septorhinoplasty or cosmetic septorhinoplasty, with or without auricular cartilage harvest

You may not qualify if:

Patients who have had a prior septorhinoplasty
Patients who have received prior head and neck radiation
Patients with a septal perforation
Patients who are medically ineligible to undergo septorhinoplasty.

Contact the study team to confirm eligibility.